- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06595251
Community Park-Based Programs for Health Promotion: Fit2Play Prospective Cohort Study (F2P)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The Fit2Play prospective cohort study examines the effects of a park-based youth physical activity afterschool program on youth participant fitness and mental health outcomes. The Fit2Play program was designed by a team of MDPROS professionals and UM faculty. It is a daily after-school park-based program (Monday-Friday, 2 PM-6 PM) that comprises (1) 60 minutes of physical activity that incorporates multiple sports (soccer, kickball, flag football) and activities from Sports, Play and Active Recreation for Kids (SPARK), a play- and evidenced-based, outcome-oriented, structured, active recreation program for children with a focus on developing and improving motor skills, movement knowledge, social and personal skills; and (2) 20-30 minutes of nutrition education lessons 1-2 times per week that incorporate EmpowerMe4Life, a health and wellness curriculum aligned to the National Health Education Standards for fifth grade and grounded in the American Heart Association's scientific recommendations in promoting heart-healthy lifestyles. Fit2Play programming is implemented by park coaches, who are hired with health and wellness training and/or education-specific background(s) with at least a high school degree. Participants are divided into younger (6-9 years) and older (10-14 years) age groups regardless of weight status, and coaches choose daily age-appropriate SPARK and other physical activities for each group. With an oversight from a registered dietician, similarly, the UM-MDPROS team has expanded the EmpowerMe4Life curriculum to include younger (6-9 years) and older (10-14 years) age group modules.
The research team includes a large community organization (Miami-Dade County Parks and Recreation Department). All consented Fit2Play participants (400-800 per year) complete a baseline (August/September) and post-test (May/June) assessment during each school year of participation that include demographic, mental health symptom questionnaires, satisfaction surveys, and on-site physical fitness and biometric measurements. Data collection is performed by a core MDPROS measurement team who are trained and certified by University of Miami School of Medicine faculty. In addition, MDPROS bachelor/master's level recreation directors oversee on-site measurement procedures and collection of all predata and postdata to ensure measurement fidelity. Data are then uploaded to a shared (parks and university) database via a data management team.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Emily M D'Agostino, DPH, MS, MEd, MA
- Phone Number: +1 919 668 8540
- Email: emily.m.dagostino@duke.edu
Study Locations
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Florida
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Miami, Florida, United States, 33128
- Recruiting
- Miami-Dade County Parks, Recreation and Open Spaces Department
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- All participants enrolled in the Miami-Dade Fit2Play study will be included in this secondary analysis
Exclusion Criteria:
- Anyone not enrolled in the Miami-Dade Fit2Play study will be excluded from this secondary analysis
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Fit2Play Program
|
Fit2Play is a daily after-school park-based program (Monday-Friday, 2 PM-6 PM) that comprises (1) 60 minutes of physical activity that incorporates multiple sports (soccer, kickball, flag football) and activities from Sports, Play and Active Recreation for Kids (SPARK), a play- and evidenced-based, outcome-oriented, structured, active recreation program for children with a focus on developing and improving motor skills, movement knowledge, social and personal skills; and (2) 20-30 minutes of nutrition education lessons 1-2 times per week that incorporate EmpowerMe4Life, a health and wellness curriculum aligned to the National Health Education Standards for fifth grade and grounded in the American Heart Association's scientific recommendations in promoting heart-healthy lifestyles.
Miami-Dade Parks and Recreation is the sponsor of the Fit2Play prospective cohort study.
Duke is conducting a secondary data analysis on data collected as part of the Fit2Play study.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in Weight
Time Frame: Baseline, 12-72 MONTHS
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Baseline, 12-72 MONTHS
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Change in Height
Time Frame: Baseline, 12-72 MONTHS
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Baseline, 12-72 MONTHS
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Change in Waist-to-Hip Circumference
Time Frame: Baseline, 12-72 MONTHS
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Baseline, 12-72 MONTHS
|
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Change in Pulse
Time Frame: Baseline, 12-72 MONTHS
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Baseline, 12-72 MONTHS
|
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Change in Blood Pressure
Time Frame: Baseline, 12-72 MONTHS
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Baseline, 12-72 MONTHS
|
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Change in PACER score
Time Frame: Baseline, 12-72 MONTHS
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Baseline, 12-72 MONTHS
|
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Change in sit-and-reach test
Time Frame: Baseline, 12-72 MONTHS
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Baseline, 12-72 MONTHS
|
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Change in number of push-ups
Time Frame: Baseline, 12-72 MONTHS
|
Baseline, 12-72 MONTHS
|
|
Change in number of sit-ups
Time Frame: Baseline, 12-72 MONTHS
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Baseline, 12-72 MONTHS
|
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Change in Kidscreen-27
Time Frame: Baseline, 12-72 MONTHS
|
Baseline, 12-72 MONTHS
|
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Change in GAD-7
Time Frame: Baseline, 12-72 MONTHS
|
Baseline, 12-72 MONTHS
|
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Change in PHQ-8
Time Frame: Baseline, 12-72 MONTHS
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Baseline, 12-72 MONTHS
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Emily D'Agostino, DPH, MS, MEd, MA, Duke University
Publications and helpful links
General Publications
- D'Agostino EM, Patel HH, Hansen E, Mathew MS, Nardi M, Messiah SE. Longitudinal analysis of cardiovascular disease risk profile in neighbourhood poverty subgroups: 5-year results from an afterschool fitness programme in the USA. J Epidemiol Community Health. 2018 Mar;72(3):193-201. doi: 10.1136/jech-2017-209333. Epub 2017 Nov 24.
- Booth JV, Messiah SE, Hansen E, Nardi MI, Hawver E, Patel HH, Kling H, Okeke D, D'Agostino EM. Objective Measurement of Physical Activity Attributed to a Park-Based Afterschool Program. J Phys Act Health. 2021 Mar 1;18(3):329-336. doi: 10.1123/jpah.2020-0162. Epub 2021 Jan 31.
- D'Agostino EM, Patel HH, Hansen E, Mathew MS, Nardi MI, Messiah SE. Effect of participation in a park-based afterschool program on cardiovascular disease risk among severely obese youth. Public Health. 2018 Jun;159:137-143. doi: 10.1016/j.puhe.2018.02.025. Epub 2018 Mar 27.
- Messiah SE, D'Agostino EM, Hansen E, Mathew MS, Okeke D, Nardi M, Kardys J, Arheart KL. Longitudinal Impact of a Park-Based Afterschool Healthy Weight Program on Modifiable Cardiovascular Disease Risk Factors in Youth. J Community Health. 2018 Feb;43(1):103-116. doi: 10.1007/s10900-017-0393-9.
- Messiah SE, D'Agostino EM, Patel HH, Hansen E, Mathew MS, Arheart KL. Sex differences in fitness outcomes among minority youth after participation in a park-based after-school program. Ann Epidemiol. 2018 Jul;28(7):432-439. doi: 10.1016/j.annepidem.2018.03.020. Epub 2018 Apr 12.
- D'Agostino EM, Patel HH, Ahmed Z, Hansen E, Sunil Mathew M, Nardi MI, Messiah SE. Impact of change in neighborhood racial/ethnic segregation on cardiovascular health in minority youth attending a park-based afterschool program. Soc Sci Med. 2018 May;205:116-129. doi: 10.1016/j.socscimed.2018.03.038. Epub 2018 Mar 27.
- Zewdie H, Zhao AY, Patel HH, Hansen E, Messiah SE, Armstrong SC, Skinner AC, Neshteruk CD, Hipp JA, D'Agostino EM. The association between neighborhood quality, youth physical fitness, and modifiable cardiovascular disease risk factors. Ann Epidemiol. 2021 May;57:30-39. doi: 10.1016/j.annepidem.2021.02.004. Epub 2021 Feb 14.
- D'Agostino EM, Patel HH, Hansen E, Mathew MS, Messiah SE. Longitudinal Effects of Transportation Vulnerability on the Association Between Racial/Ethnic Segregation and Youth Cardiovascular Health. J Racial Ethn Health Disparities. 2021 Jun;8(3):618-629. doi: 10.1007/s40615-020-00821-8. Epub 2020 Sep 2.
- D'Agostino EM, Patel HH, Ahmed Z, Hansen E, Mathew MS, Nardi MI, Messiah SE. Natural experiment examining the longitudinal association between change in residential segregation and youth cardiovascular health across race/ethnicity and gender in the USA. J Epidemiol Community Health. 2018 Jul;72(7):595-604. doi: 10.1136/jech-2018-210592. Epub 2018 May 10.
- D'Agostino EM, Patel HH, Hansen E, Mathew MS, Nardi MI, Messiah SE. Does transportation vulnerability explain the relationship between changes in exposure to segregation and youth cardiovascular health? Health Place. 2019 May;57:265-276. doi: 10.1016/j.healthplace.2019.04.002. Epub 2019 May 24.
- Patel HH, Messiah SE, Hansen E, D'Agostino EM. The relationship between transportation vulnerability, school attendance, and free transportation to an afterschool program for youth. Transportation. 2021 Oct;48(5):2315-33.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Vascular Diseases
- Cardiovascular Diseases
- Mental Disorders
- Nutrition Disorders
- Overnutrition
- Body Weight
- Behavioral Symptoms
- Pathological Conditions, Signs and Symptoms
- Behavior
- Nutritional and Metabolic Diseases
- Signs and Symptoms
- Personal Satisfaction
- Overweight
- Obesity
- Hypertension
- Anxiety Disorders
- Depression
- Prehypertension
- Psychological Well-Being
- Motor Activity
Other Study ID Numbers
- Pro00105669
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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